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[Federal Register Volume 88, Number 234 (Thursday, December 7, 2023)]
[Notices]
[Pages 85290-85291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26805]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3451-PN]

Medicare and Medicaid Programs; Application From the Joint 
Commission (TJC) for Initial Approval of Its Rural Health Clinic (RHC) 
Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Notice with request for comment.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from the Joint Commission (TJC) for initial recognition as 
a national accrediting organization (AO) for rural health clinics 
(RHCs) that wish to participate in the Medicare or Medicaid programs. 
The statute requires that within 60 days of receipt of an 
organization's complete application, the Centers for Medicare & 
Medicaid Services (CMS) publish a notice that identifies the national 
accrediting body making the request, describes the nature of the 
request, and provides at least a 30-day public comment period.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, by January 8, 2024.

ADDRESSES: In commenting, refer to file code CMS-3451-PN.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3451-PN, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3451-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Caecilia Blondiaux (410) 786-2190.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments. We will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the individual will take actions to harm the individual. We 
continue to encourage individuals not to submit duplicative comments. 
We will post acceptable comments from multiple unique commenters even 
if the content is identical or nearly identical to other comments.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a rural health clinic (RHC) provided certain 
requirements are met by the RHC. Section 1861(aa)(1) and (2) and 
1905(l)(1) of the Social Security Act (the Act), establishes distinct 
criteria for facilities seeking designation as an RHC. Regulations 
concerning provider agreements are at 42 CFR part 489 and those 
pertaining to activities relating to the survey and certification of 
facilities are at 42 CFR part 488, subpart A. The regulations at 42 CFR 
part 491, subpart A specify the conditions that a RHC must meet to 
participate in the Medicare program, the scope of covered services, and 
the conditions for Medicare payment for RHCs are set forth at 42 CFR 
405, subpart X.
    Generally, to enter into an agreement, a RHC must first be 
certified by a State survey agency as complying with the conditions or 
requirements set forth in

[[Page 85291]]

part 491 of CMS regulations. Thereafter, the RHC is subject to regular 
surveys by a State survey agency to determine whether it continues to 
meet these requirements.
    However, there is an alternative to surveys by State agencies. 
Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national accrediting 
organization (AO) that all applicable Medicare conditions are met or 
exceeded, we will deem those provider entities as having met the 
requirements. Accreditation by an AO is voluntary and is not required 
for Medicare participation.
    If an AO is recognized by the Secretary of Health and Human 
Services as having standards for accreditation that meet or exceed 
Medicare requirements, any provider entity accredited by the national 
accrediting body's approved program would be deemed to meet the 
Medicare conditions. A national AO applying for CMS approval of their 
accreditation program under 42 CFR part 488, subpart A must provide CMS 
with reasonable assurance that the AO requires the accredited provider 
entities to meet requirements that are at least as stringent as the 
Medicare conditions. Our regulations concerning the approval of 
accrediting organizations are set forth at Sec.  488.5.
    The Joint Commission (TJC) is requesting initial approval by CMS 
for its RHC program.

II. Approval of Deeming Organization

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.5 
require that our findings concerning review and approval of a national 
accrediting organization's requirements consider, among other factors, 
the applying accrediting organization's requirements for accreditation; 
survey procedures; resources for conducting required surveys; capacity 
to furnish information for use in enforcement activities; monitoring 
procedures for provider entities found not in compliance with the 
conditions or requirements; and ability to provide us with the 
necessary data for validation.
    Section 1865(a)(3)(A) of the Act further requires that we publish, 
within 60 days of receipt of an organization's complete application, a 
notice identifying the national accrediting body making the request, 
describing the nature of the request, and providing at least a 30-day 
public comment period. We have 210 days from the receipt of a complete 
application to publish notice of approval or denial of the application.
    The purpose of this proposed notice is to inform the public of 
TJC's request for initial approval for its RHC accreditation program. 
This notice also solicits public comment on whether TJC's requirements 
meet or exceed the Medicare conditions of participation (CoPs) for 
RHCs.

III. Evaluation of Deeming Authority Request

    TJC submitted all the necessary materials to enable us to make a 
determination concerning its request for continued approval of its RHC 
accreditation program. This application was determined to be complete 
on October 27, 2023. Under section 1865(a)(2) of the Act and our 
regulations at Sec.  488.5 (Application and re-application procedures 
for national accrediting organizations), our review and evaluation of 
TJC will be conducted in accordance with, but not necessarily limited 
to, the following factors:
     The equivalency of TJC's standards for RHCs as compared 
with CMS' RHC CoPs.
     TJC's survey process to determine the following:
    ++ The composition of the survey team, surveyor qualifications, and 
the ability of the organization to provide continuing surveyor 
training.
    ++ The comparability of TJC's processes to those of State agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited RHCs.
    ++ TJC's processes and procedures for monitoring RHCs found out of 
compliance with TJC's program requirements. These monitoring procedures 
are used only when TJC identifies noncompliance. If noncompliance is 
identified through validation reviews or complaint surveys, the State 
survey agency monitors corrections as specified at Sec.  488.9(c).
    ++ TJC's capacity to report deficiencies to the surveyed RHCs and 
respond to the RHC's plan of correction in a timely manner.
    ++ TJC's capacity to provide us with electronic data and reports 
necessary for effective validation and assessment of the organization's 
survey process.
    ++ The adequacy of TJC's staff and other resources, and its 
financial viability.
    ++ TJC's capacity to adequately fund required surveys.
    ++ TJC's policies with respect to whether surveys are announced or 
unannounced, to assure that surveys are unannounced.
    ++ TJC's policies and procedures to avoid conflicts of interest, 
including the appearance of conflicts of interest, involving 
individuals who conduct surveys or participate in accreditation 
decisions.
    ++ TJC's agreement to provide us with a copy of the most current 
accreditation survey together with any other information related to the 
survey as we may require (including corrective action plans).

IV. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping, or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Trenesha Fultz-Mimms, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-26805 Filed 12-6-23; 8:45 am]
BILLING CODE 4120-01-P
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